RecruitingNCT06659393

Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)

Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure, CLCZ696F1401)

Sponsor

Novartis Pharmaceuticals

Enrollment

30 participants

Start Date

Dec 19, 2024

Study Type

OBSERVATIONAL

Conditions

Pediatric Chronic Heart Failure

Summary

This is multicenter, single-arm, non-interventional, centrally enrolled specified drug-use survey to investigate the safety of Entresto Tablets or Entresto Granules for Pediatric in pediatric patients with chronic heart failure in actual clinical settings for up to 52 weeks after administration.

Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This observational study tracks how a heart failure medication called Entresto (sacubitril/valsartan) works in children and adolescents with chronic heart failure in real-world clinical settings in Japan. It monitors safety and effectiveness in this younger age group. **You may be eligible if...** - You are a child or adolescent between 1 and 17 years old - You are starting Entresto for the first time for chronic heart failure - A legal guardian has provided written consent **You may NOT be eligible if...** - You have previously taken Entresto or similar medications - You have a known allergy to Entresto's ingredients - You are currently taking certain blood pressure medications called ACE inhibitors - You have a history of serious facial or throat swelling (angioedema) - You have certain other contraindications listed on the Entresto label Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(28)

Novartis Investigative Site

Ōbu, Aichi-ken, Japan

Novartis Investigative Site

Toyoake, Aichi-ken, Japan

Novartis Investigative Site

Kurume, Fukuoka, Japan

Novartis Investigative Site

Kurume, Fukuoka, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Tsukuba, Ibaraki, Japan

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Novartis Investigative Site

Yokohama, Kanagawa-ku, Japan

Novartis Investigative Site

Tsu, Mie-ken, Japan

Novartis Investigative Site

Nagasaki, Nagasaki, Japan

Novartis Investigative Site

Ōmura, Nagasaki, Japan

Novartis Investigative Site

Hidaka, Saitama, Japan

Novartis Investigative Site

Saitama, Saitama, Japan

Novartis Investigative Site

Hamamatsu, Shizuoka, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Novartis Investigative Site

Fuchū, Tokyo, Japan

Novartis Investigative Site

Fuchū, Tokyo, Japan

Novartis Investigative Site

Ōta-ku, Tokyo, Japan

Novartis Investigative Site

Setagaya-ku, Tokyo, Japan

Novartis Investigative Site

Shinagawa-ku, Tokyo, Japan

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Novartis Investigative Site

Toyama, Toyama, Japan

Novartis Investigative Site

Akita, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Kumamoto, Japan

Novartis Investigative Site

Okayama, Japan

View Full Details on ClinicalTrials.gov

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NCT06659393